Casey Reading Center

Anatomical and functional clinical research

The Casey Reading Center (CRC) is a team of physicians, scientists and staff who are focused on partnering with sponsors to ensure the highest level of quality and insight is derived from clinical trials. Since our initial inception in 2009 we have developed FDA-compliant standard operating procedures and quality assurance measures determined to be "best in class" by external auditors. This quality allows us to offer the most sophisticated analysis platforms available in ophthalmic imaging and functional assessment.  

Pre-trial support

  • Clinical trial design and Endpoint development  

  • Development of clinical site manual of procedures  

  • Certification of clinical sites  

Trial Support

  • Internal validation of key grading criteria across modalities  

  • Clinical site support  

  • Real-time sponsor and CRO access to clinical trial reads and reports  

Post-Trial Support

  • Sponsor-tailored data outputs  

  • Research  

Our team

  • Retinal Imaging: Brandon Lujan, M.D.; Maria Parker, M.D.; Ambar Faridi, M.D.; Audra Miller, M.D. 

  • Quality control assessments: Ellie Chegarnov, C.O.T.; Peter Steinkamp, M.S.; Melissa Krahmer, M.S.; Maria Parker, M.D.; Edeleidys Sanchez, M.D.; Audra Miller, M.D.; Alex Tomlinson, B.S.; Jon Marquett; Elise Nettle; Nicole Green 

  • Clinical trial design: Richard Weleber, M.D., Mark Pennesi, M.D., Ph.D.; Brandon Lujan, M.D. 

  • Endpoint development: Richard Weleber, M.D., Mark Pennesi, M.D., Ph.D.; Brandon Lujan, M.D., Maria Parker, M.D. 

  • Site certification and Training: Albert Romo, Ellie Chegarnov, Susan Nolte 

  • Project managers: Mitra Adeli, M.S.; Jennifer Simer, B.S.; Christine Long, B.S.; Albert Romo 

Consultants

  • Key Insights: David Wilson, M.D. and Sigrid Button 

  • Genetics, ERG and Visual Fields: Mark Pennesi M.D., Ph.D. 

  • Statistics: Dongseok Choi, Ph.D. 

  • Visual Field Technical Director: Richard Weleber, M.D. 

  • OCT Angiography Technical Director: Yali Jia, Ph.D. 

Our infrastructure - security, database input/output

Data infrastructure and security

The CRC offers interactive and secure web-based software for the management of clinical trials. It is remotely accessible, allowing easy upload of data and image files from clinical sites while allowing real time access for the CRC, sponsors and clinical research organizations. Due to its accessibility, we have taken great pains to ensure the data housed within our database is electronically secured. The reading center software, database and server are FDA compliant for electronic records, according to 21 CFR Part 11, and we follow the FDA guidance put forth on General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The data center and servers are maintained by a specialized team of information technology professionals. Data is backed-up daily and stored off-site. Servers are protected by SSL encryption, ongoing virus and malware surveillance, as well as scanning at the time of upload.  

Ongoing and final reports

We provide real-time assessment of data quality for sponsors to access as well as quarterly reports. Flags for poor data are generated for sponsors and for clinical sites and remedial actions are planned if necessary. The CRC provides endpoint exports in XML format. The sponsor can develop an automated import of the XML file for data analysis for timely review at scientific conferences or Data and Safety Monitoring Boards.

Our services

The Casey Reading Center offers a full-service experience, and sponsors can choose which options will meet their goals. We offer study consultation on clinical trial design and endpoint determination for each of the modalities that we offer, trial certification, assessment of anatomical and functional clinical trial endpoints. In addition, we offer post-hoc research into the data to investigate signals that may have arisen during the trial or found from others research.   

We look forward to working with sponsors from the inception of a clinical trial through its conclusion to provide the best experience possible in obtaining verified data.